Bioventus Announces First Patients Enrolled in BONES Study for EXOGEN®

13.9.2017 12:37 | Business Wire

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Bioventus,
a global leader in orthobiologics, today announced the first patients
have been enrolled in its BONES (Bioventus Observational
Non-interventional EXOGEN Studies) clinical development program.
BONES includes three observational, non-interventional,
direct-to-patient studies designed to collect real world data on the use
of the EXOGEN
Ultrasound Bone Healing System. EXOGEN uses safe, effective
low-intensity pulsed ultrasound (LIPUS) to help stimulate the body’s
natural bone healing process.

EXOGEN Ultrasound Bone Healing System from Bioventus (Photo: Business Wire)

The
BONES studies will compare the incidence of fracture nonunions in
patients utilizing EXOGEN with patients from a national health
insurance claims database who received standard of care alone. The
studies will include long and small bones of upper and lower extremities
and the unique design of BONES was discussed with FDA during its
development. Its primary endpoint is defined as the ability of EXOGEN
to mitigate the risk of a fracture progressing to nonunion in the
presence of known risk factors.

“We are excited to build on the vast clinical experience available on
this established therapy and further develop our knowledge on the real
world effectiveness of EXOGEN, by assessing its value in reducing
nonunions, a highly disabling complication that also carries a
significant societal burden,” said Alessandra Pavesio, Senior Vice
President and Chief Science Officer, Bioventus. “Accomplishing this
ambitious goal requires an alternative methodology to randomized
controlled trials and involves epidemiologically grounded research of
large patient cohorts enrolled both prospectively, and within the big
data available from US health insurance claims.”

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven,
cost-effective products that help people heal quickly and safely. Its
mission is to make a difference by helping patients resume and enjoy
active lives. The company has two product portfolios for orthobiologics, Bioventus
Active Healing Therapies and Bioventus
Surgical that make it a global leader in active orthopaedic healing.
Its EXOGEN® Ultrasound Bone Healing System uses safe,
effective low intensity pulsed ultrasound (LIPUS) to stimulate the
body’s natural healing process. EXOGEN has been used to treat more than
1 million patients worldwide and numerous regulatory agencies including
the FDA, Health Canada, BSI, TGA, Medsafe, UAE Ministry of Health and
SFDA have granted their approval of the product. Today it is the leading
bone healing system in the market with complaints for lack of efficacy
averaging less than 1%.

Built on a commitment to high quality standards, evidence-based medicine
and strong ethical behavior, Bioventus is a trusted partner for
physicians worldwide. For more information, visit www.BioventusGlobal.com
and follow the company on Twitter @Bioventusglobal.

Bioventus, the Bioventus logo, and EXOGEN are registered trademarks of
Bioventus LLC.

EXOGEN - Summary of Indications for Use in the US

*Summary of Indications for Use: The EXOGEN Ultrasound Bone Healing
System is indicated for the non-invasive treatment of established
non-unions* excluding skull and vertebra. In addition, EXOGEN is
indicated for accelerating the time to a healed fracture for fresh,
closed, posteriorly displaced distal radius fractures and fresh, closed
or Grade I open tibial diaphysis fractures in skeletally mature
individuals when these fractures are orthopaedically managed by closed
reduction and cast immobilization. There are no known contraindications
for the EXOGEN device. Safety and effectiveness has not been established
for individuals lacking skeletal maturity; pregnant or nursing women;
patients with cardiac pacemakers; on fractures due to bone cancer; or on
patients with poor blood circulation or clotting problems. Some patients
may be sensitive to the ultrasound gel. Full prescribing information can
be found in product labeling, at www.exogen.com
or by contacting customer service at 1-800-836-4080. *A nonunion is
considered to be established when the fracture site shows no visibly
progressive signs of healing.